Background: The aim of this study was to evaluate the efficacy and safety of COVID-19 vaccines in patients undergoing haemodialysis in Italy compared to the general population. Methods: In this cohort study, 118 dialysis centres from 18 Italian Regions participated. Individuals older than 16 years on dialysis treatment for at least 3 months, who provided informed consent were included. We collected demographic and clinical information, as well as data on vaccination status, hospitalisations, access to intensive care units and adverse events. We calculated the incidence, hospitalisation, mortality, and fatality rates in the vaccinated dialysis cohort, adjusted for several covariates. The incidence rates of infection in the dialysis cohort and the general population were compared through Standardised Incidence Rate Ratio. Results: The study included 6555 patients vaccinated against SARS-CoV-2 infection according to the schedule recommended in Italy. Between March 2021 and May 2022, there were 1096 cases of SARS-CoV-2 infection, with an incidence rate after completion of the three-dose vaccination cycle of 37.7 cases per 100 person-years. Compared to the general population, we observed a 14% reduction in the risk of infection for patients who received three vaccine doses (Standardised Incidence Rate Ratio: 0.86; 95% Confidence Interval: 0.81–0.91), whereas no statistically significant differences were found for COVID-19-related hospitalisations, intensive care unit admissions or death. No safety signals emerged from the reported adverse events. Conclusions: The vaccination program against SARS-CoV-2 in the haemodialysis population showed an effectiveness and safety profile comparable to that seen in the general population. Graphical abstract: [Figure not available: see fulltext.]
Safety and efficacy of COVID-19 vaccines in patients on dialysis: a multicentre cohort study in Italy / Menniti-Ippolito, Francesca; Mele, Alfonso; Da Cas, Roberto; De Masi, Salvatore; Chiarotti, Flavia; Fabiani, Massimo; Baglio, Giovanni; Traversa, Giuseppe; Colavita, Francesca; Castilletti, Concetta; Salomone, Mario; Zoccali, Carmine; Messa, Piergiorgio; Covidvaxdia Study, Group; Maggioni, Aldo Pietro; Lorimer, Andrea; Ceseri, Martina; Baldini, Ester; Bianchini, Francesca; Sarti, Laura; Mariano, Andrea; Alessi, Eva; Di Liberato, Lorenzo; Amoroso, Luigi; Spetrino, Nicola; Di Giovanni, Milva; Sapio, Carlo; Figlia, Irma; Pititto, Roberto; Papalia, Teresa; Greco, Rosita; Leone, Francesca; D'Agostino, Francesco Maria; Campolo, Mariangela; La Gamba, Maria Rosa; Mallamaci, Francesca; Panuccio, Vincenzo; Parlongo, Giovanna; Natale, Giuseppe; Tramontana, Domenico; Figliano, Ivania Maria; Vitiello, Santo; Frangiosa, Anna Maria; Caserta, Domenico; Acconcia, Pasqualina; Paudice, Nunzia; De Maio, Alfonso; Cascone, Salvatore; Siani, Marilina; Cioffi, Mario; Romanyuk, Nataliya; Pagnano, Franca; De Donato, Antonio; Satta, Ersilia; Perna, Alessandra; Trepiccione, Francesco; Cerrone, Alessandro; Garofalo, Gianluca; Marinelli, Giancarlo; D'Amato, Roberta; De Felice, Enrico; Vacca, Alfredo; Coppola, Salvatore; Cuomo, Vincenzo; Iavarone, Maria Palma; Ciotola, Annalisa; Puglia, Vincenzo; Granato, Pio; Lamberti, Carla; Capasso, Giorgio; Bonanno, Domenico; Ventre, Marco; Amendola, Veronica; Cappabianca, Fabio; Mancini, Elena; Ricci, Davide; Cannarile, Daniela Cecilia; Benevento, Roberta; Perciaccante, Bianca; Storari, Alda; Battaglia, Yuri; Piva, Giovanni; Mosconi, Giovanni; Spazzoli, Alessandra; Bruno, Paolo Ferdinando; Ambri, Katia; Veterani, Barbara; Signorotti, Sara; Mandreoli, Marcora; Rapanà, Renato Mario; Benedetto, Maria Teresa; Patregnani, Laura; Zambelli, Maddalena; Alfano, Gaetano; Gregorini, Mariacristina; Mattei, Silvia; Iannuzzella, Francesca; Pelizzaro, Elena; Camparini, Luca; Battaglino, Giuseppe; Romanini, Dino; Irlando, Antonio; Celik, Lojze; Natale, Giuseppa; Torre, Maria Cristina; Umbro, Ilaria; Pirozzi, Nicola; Fazzari, Loredana; Pantano, Lucia; Paone, Antonio; Galliani, Marco; Baglio, Veronica; Moscaritolo, Eleonora; Fierimonte, Sabrina; De Cristofaro, Maria; Nebuloso, Elena; Menè, Paolo; Festuccia, Francesca Romana; Talarico, Giulia; Fofi, Claudia; Bracaccia, Maria Elena; Cioffi, Ernesto Anselmo; Mazza, Fabio; Polito, Pasquale; Micarelli, David; Addesse, Roberto; Tartaglione, Lida; Feriozzi, Sandro; Rovere, Francesca Romana Della; Chipilova, Natalia; Manzuoli, Micol; Sacco, Paolo; Ansaldo, Francesca; Bottaro, Chiara; Marre, Sonia; Viazzi, Francesc; Falqui, Valeria; Conti, Novella; Parodi, Angelica; Zanetti, Valentina; Cappadona, Francesca; Speciale, Andrea; Mancuso, Giancarlo; Repetto, Monica; Vigo, Emanuela Chiara; Montenotte, Cairo; Murgia, Anna Maria; Ruggenenti, Piero; Ondei, Patrizia; Condemi, Carmela Giuseppina; Bernardi, Sivia; Scolari, Francesco; Gaggia, Paola; Alberico, Federico; Manenti, Chiara; Valzorio, Brunella; Camerini, Corrado; Gallico, Agnese; Tonoli, Michela; Daffara, Federico; Zubbani, Roberto; Guerini, Simona; Zappa, Mattia; Zambetti, Nicole; Gassa, Alessandra Dalla; Baldan, Paola; Fraizzoli, Luca; Bisegna, Sergio; Palmieri, Nicola; Petrilli, Marco; Mandanici, Giusy; Stefani, Francesca Serena; Ogliari, Valeria; Tantardini, Cristina; Malberti, Fabio; Pecchini, Paola; La Milia, Vincenzo; Guastoni, Carlo Maria; Neri, Annalisa; Cornacchiari, Marina; Farina, Marco; Barbisoni, Francesco; Maggio, Milena; Cozzolino, Mario; Cassia, Matthias; Frittoli, Michela; Magagnoli, Lorenza; De Leonardis, Rossella; Casazza, Roberta; Vettoretti, Simone; Grimaldi, Emanuele; Abinti, Matteo; Carminati, Francesca Maria Ida; Giuliani, Silvia; Benedetti, Matteo; Delfrate, Nicholas; Colombo, Elisa; Cervesato, Angela; Minetti, Enrico Eugenio; Montoli, Alberto; Brunati, Chiara; Li Bergolis, Valerae; Galllieni, Maurizio; Airaghi, Cristina; Buskermolen, Monique; Cosmai, Laura; Orani, Maria Antonietta; De Salvo, Cristina; Vezzoli, Giuseppe; Slaviero, Giorgio; Lanzani, Chiara; Pieruzzi, Federico; Contaldo, Gina; Trezzi, Barbara; Rampino, Teresa; Grosjean, Fabrizio; Borille, Paola; Esposito, Ciro; Sileno, Giuseppe; Arazzi, Marta; Melfa, Gianvincenzo; Tettamanti, Mariagiulia; Tosetti, Anna; D'Amico, Marco; Magatti, Maria Giulia; Peiti, Silvia; Pedrini, Luciano; Feliciani, Annalisa; Pezzini, Elena; Bertoli, Silvio Volmer; Ciurlino, Daniele; Tedoldi, Silvia; Prettico, Vania; Magni, Giulia Maria; Gazo, Antonietta; Nai, Maurizio; Muciaccia, Silvia; Battini, Graziana; Merlino, Lino; Casanova, Paola; Lencia, Federica; Ricci, Maddalena; Ranghino, Andrea; Valente, Mauro; Finale, Carolina; Guerrini, Eleonora; Canonici, Marta; Santarelli, Stefano; Agostinelli, Rosa Maria; Di Luca, Marina; Martello, Mauro; Silvestri, Cristina; Bertuzzi, Veronica; Cardillo, Assunta; Nastasi, Valentina; Belcastro, Sara; Manganaro, Marco; Parodi, Emanuele Luigi; Vaccaro, Valentina; Giolito, Antonella; Cusinato, Stefano; Battista, Michele; Ragazzoni, Elena; Carpani, Paola Marcella; Stramignoni, Emanuele; Savoldi, Silvana; Martina, Guido; Deagostini, Chiara; Magnetti, Marica; Bussolino, Stefania; Ventrella, Federica; Santi, Sonia; Marengo, Marita; Falconi, Daniela; Serra, Ilaria; Besso, Luca; Diena, Davide; Notti, Doriana Chiari; David, Paola; Gravellone, Luciana; Vitale, Corrado; Berutti, Silvia; Ganci, Silvia; Vigotti, Federica Neve; Cesano, Giulio; Borzumati, Maurizio; Bio, Patrizia; Gioira, Stefania; Filiberti, Oliviero; Pagani, Fabiola; Ottone, Simonetta; Lomonte, Carlo; Montinaro, Vincenzo; Pepe, Vito; Manno, Elisabetta; Di Paolo, Salvatore; Natalicchio, Luigi; Gallo, Carmela; Pansini, Francesca; Varvara, Rossella; D'Elia, Filomena; Coviello, Nicola; Prisciandaro, Concetta; Vernò, Lucia; Misceo, Fernanda; Zazzera, Pierfelice; Matrella, Antonella; Gesualdo, Loreto; Di Palma, Anna Maria; Pronzo, Virginia; Cassone, Federica; Di Paolo, Salvatore; Piccolo, Tiziana; Porcelluzzi, Dora; Di Franco, Antonella; Giannetto, Mario; Villani, Chiara; Vernaglione, Luigi; Specchio, Angelo; Stoico, Laura; Stallone, Giovanni; Losappio, Vincenzo; Infante, Barbara; Morrone, Luigi; Marangi, Anna Lisa; Rodio, Angela; D'Altri, Christian; Venerito, Paolo; Cianciotta, Francesca; Aucella, Filippo; Ferrara, Gaetano; Nardella, Anna Rachele; Morrone, Luigi Francesco Pio; Corallo, Maria Grazia; D'Ettorre, Giuseppina; Caccetta, Francesco; Gianfreda, Davide; Pani, Antonello; Cabiddu, Gianfranca; Caria, Stefania; Romano, Maria Maddalena; Adamo, Ciro; Battaglia, Giovanni Giorgio; Pocorobba, Barbara; Prencipe, Emanuela; Saraceno, Margherita; Scuderi, Luana; Randone, Salvatore; Bruno, Francesca; Marchese, Rossella Rita; Granata, Antonio; Puliatti, Daniela; Marcantoni, Carmelita; Zanoli, Luca; D'Anca, Ambra; Santoro, Domenico; Gembillo, Guido; Giuffrida, Alfio Eduardo; Labbozzetta, Vincenzo; Tralongo, Angelo; Li Cavoli, Gioacchino; Zaggarigo, Carmela; Conti, Paolo; Giovannini, Sofia; Farsetti, Silvia; Dattolo, Pietro Claudio Giovanni; Tsalouchos, Aris; Michelassi, Stefano; Gallo, Marco; Bandor, Irene; Sami, Nadia; Riccomi, Daniela; Traversari, Lorena; Tabbi, Maria Grazia; Bonincontro, Maria Luisa; Bonell, Vera; Brunori, Giuliano; Zarantonello, Diana; Laudon, Alessandro; Selvi, Antonio; Santoni, Stefania; Massimiani, Davide; Rossi, Davide; Calò, Lorenzo; Rossi, Barbara; Scaparrotta, Giuseppe; Fiorini, Fulvio; Iacono, Valentina; Rugiu, Carlo; Slaviero, Monica; Nordio, Maurizio; Puggia, Riccarda Maria; Caberlotto, Adriana; Scanferla, Flavio; Casoria, Vincenzo; Gramegna, Federica; Meneghel, Gina; Filippi, Ilenia; Giacomini, Anna; Ronco, Claudio; Giuliani, Anna; Manani, Sabrina Milan; Zanella, Monica. - In: JN. JOURNAL OF NEPHROLOGY. - ISSN 1724-6059. - 36:(2023), pp. 2013-2022. [10.1007/s40620-023-01708-7]
Safety and efficacy of COVID-19 vaccines in patients on dialysis: a multicentre cohort study in Italy
Natale, GiuseppeMembro del Collaboration Group
;Mancini, ElenaMembro del Collaboration Group
;Giuliani, SilviaMembro del Collaboration Group
;Benedetti, MatteoMembro del Collaboration Group
;Ricci, MaddalenaMembro del Collaboration Group
;Ranghino, AndreaMembro del Collaboration Group
;Finale, CarolinaMembro del Collaboration Group
;Canonici, MartaMembro del Collaboration Group
;Santarelli, StefanoMembro del Collaboration Group
;Gallo, MarcoMembro del Collaboration Group
;Rossi, DavideMembro del Collaboration Group
;
2023-01-01
Abstract
Background: The aim of this study was to evaluate the efficacy and safety of COVID-19 vaccines in patients undergoing haemodialysis in Italy compared to the general population. Methods: In this cohort study, 118 dialysis centres from 18 Italian Regions participated. Individuals older than 16 years on dialysis treatment for at least 3 months, who provided informed consent were included. We collected demographic and clinical information, as well as data on vaccination status, hospitalisations, access to intensive care units and adverse events. We calculated the incidence, hospitalisation, mortality, and fatality rates in the vaccinated dialysis cohort, adjusted for several covariates. The incidence rates of infection in the dialysis cohort and the general population were compared through Standardised Incidence Rate Ratio. Results: The study included 6555 patients vaccinated against SARS-CoV-2 infection according to the schedule recommended in Italy. Between March 2021 and May 2022, there were 1096 cases of SARS-CoV-2 infection, with an incidence rate after completion of the three-dose vaccination cycle of 37.7 cases per 100 person-years. Compared to the general population, we observed a 14% reduction in the risk of infection for patients who received three vaccine doses (Standardised Incidence Rate Ratio: 0.86; 95% Confidence Interval: 0.81–0.91), whereas no statistically significant differences were found for COVID-19-related hospitalisations, intensive care unit admissions or death. No safety signals emerged from the reported adverse events. Conclusions: The vaccination program against SARS-CoV-2 in the haemodialysis population showed an effectiveness and safety profile comparable to that seen in the general population. Graphical abstract: [Figure not available: see fulltext.]| File | Dimensione | Formato | |
|---|---|---|---|
|
Menniti-Ippolito_Safety-efcacy-COVID‑19-vaccines_2023.pdf
Solo gestori archivio
Descrizione: Safety and efcacy of COVID‑19 vaccines in patients on dialysis: a multicentre cohort study in Italy
Tipologia:
Versione editoriale (versione pubblicata con il layout dell'editore)
Licenza d'uso:
Tutti i diritti riservati
Dimensione
830.97 kB
Formato
Adobe PDF
|
830.97 kB | Adobe PDF | Visualizza/Apri Richiedi una copia |
I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
